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Yang et al. Anti-PD-1/CTLA-4 Dual Immunotherapy for LARC

NCT07596290 · Status: NOT_YET_RECRUITING · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 342

Last updated 2026-05-22

No results posted yet for this study

Summary

This is a prospective, multicenter, randomized controlled trial aimed at comparing different radiotherapy fractionation regimens combined with sequential dual immunotherapy versus traditional chemoradiotherapy in neoadjuvant treatment for locally advanced rectal cancer (LARC). A total of 342 pMMR/MSS LARC patients will be enrolled and randomly assigned in a 1:1:1 ratio to short-course radiotherapy (5×5Gy) followed by sequential dual immunotherapy (paromlimab + tuvonralimab + CAPEOX), long-course radiotherapy followed by sequential dual immunotherapy, or conventional long-course chemoradiotherapy. The primary endpoint is the complete response rate (pCR + cCR). Secondary endpoints include the proportion of patients adopting the "watch-and-wait" strategy, disease-free survival, overall survival, and safety. This study innovatively explores the synergistic mechanism of different radiotherapy fractionations with dual immunotherapy, optimizes the timing of immunotherapy initiation, and constructs a clinical-imaging-pathology multimodal efficacy prediction model, aiming to advance LARC treatment from empirical to precision therapy while achieving organ and function preservation.

Conditions

  • Locally Advanced Rectal Adenocarcinoma
  • Neoadjuvant Chemoradiation
  • Neoadjuvant Immunotherapy

Interventions

RADIATION

Short-course radiotherapy

Arm A receive short-course radiotherapy

RADIATION

Long-course radiotherapy

Arm B and C will receive long-course radiotherapy

DRUG

Immunotherapy

Anti-PD-1/CTLA-4 Dual Immunotherapy (paromlimab and Tuvonralimab)

Sponsors & Collaborators

  • Peking University Cancer Hospital & Institute

    collaborator OTHER

  • Peking Union Medical College

    collaborator OTHER

  • Beijing Friendship Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-05-15
Primary Completion
2028-12-31
Completion
2030-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07596290 on ClinicalTrials.gov